Identity
- Trade Name
- Air LTE EUDAMEDAxiom Air LTE FDA UDI
- Generic Name
- Air-filled chair cushion FDA UDI
- Device Name
- Air-filled, adjustable cushion designed for use with wheelchairs. Cushion with standard cover. FDA UDI
- Model / Reference
- Seating EUDAMEDXLTE1618 EUDAMEDFDA UDI
- Description
- Air-filled, adjustable cushion designed for use with wheelchairs. Cushion with standard cover. FDA UDI
Identifiers
- Catalog Number
- XLTE1618 FDA UDI
- Primary DI / UDI-DI
- 00840363305776 EUDAMEDFDA UDI
- Basic UDI-DI
- 08403633SEATINGK7 EUDAMED
- FDA Product Code
- KIC FDA UDI
- EMDN Code
- Y122406 BELTS, SEATS AND ARMRESTS FOR WHEELCHAIRS EUDAMED
- GMDN Term
- Air-filled chair cushion FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3175 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Air LTE by Ki Mobility, Llc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08403633SEATINGK7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ki Mobility LLC
- EUDAMED SRN
- US-MF-000012633
- Authorised Representative
- Etac Supply Center AB SE-AR-000001601
Sources (2)
- EUDAMED a787f256-3490-4871-9cd5-5ffaa83206c6 61 fields · synced Jul 30, 2026
- FDA UDI 28abcebb-42e7-44cd-8ec1-2f162485a096 36 fields · synced May 30, 2026